FLUOPANC-trial - Fluorescence-guided Surgery of Pancreatic and Bileduct Tumors Using cRGD-ZW800-1

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

November 9, 2022

Primary Completion Date

May 23, 2024

Study Completion Date

May 23, 2024

Conditions
Pancreas AdenocarcinomaCholangiocarcinoma
Interventions
DRUG

CRGD-ZW800-1

Intravenous single bolus injection of the targeted NIR fluorophore cRGD-ZW800-1. This targeted 800nm zwitterionic fluorophore developed by the Hospital Pharmacy Department of LUMC consists of the fluorophore ZW800-1 conjugated to the cRGD peptide

DEVICE

Intraoperative near-infrared fluorescence imaging

Intraoperative imaging will be performed with at least one of the following CE-marked near-infrared (NIR) fluorescence imaging systems: Quest Spectrum imaging platform (v2/3.0) for open-procedures, the Olympus or Karl-Storz system for the diagnostic laparoscopy or the Intuitive Surgical Da Vinci Xi (Firefly-mode) for minimally invasive robot-assisted procedures. With a NIR-imaging system a potential fluorescent signal of the tumor can be evaluated. Furthermore, the Quest Spectrum platform will also be used for evaluation of ex-vivo fluorescence of resected tissue on the back table (Back table imaging) and pathology department (ex-vivo imaging), which shall be performed during and after every procedure.

Trial Locations (1)

2300RC

Leiden University Medical Center, Leiden

All Listed Sponsors
lead

Leiden University Medical Center

OTHER